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SureSmile® Aligners for Malocclusion

This study is looking at how well SureSmile® Clear Aligners work to straighten teeth in adults with malocclusion (a misalignment of teeth). Researchers want to see how accurate different types of tooth movements are when using these aligners. They are also comparing three different designs of the aligners: Scalloped, Straight, and Straight Extended. You might be able to join if you are 18 or older and have permanent teeth. The study will measure how accurately your teeth move from the start to the end of your aligner treatment, which typically lasts 6 to 18 months. The current recruitment status is unclear.

Study design
This is a multicenter study involving 90 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
You will have visits at the start and end of your aligner treatment, which will last on average 6-18 months.
Compensation
Not stated in the trial record.
Follow-up
Tooth movement accuracy is measured at the start and end of aligner treatment, which is on average 6-18 months after treatment begins.

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NCT07290790

A Prospective Multicenter Clinical Investigation Evaluating the Accuracy of the Trimline Design When Treated With SureSmile® Aligners.

Recruiting
NAAges 18+InterventionalTreatment
Dentsply Sirona Implants and Consumables
~90 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:SureSmile® Clear Aligners

At a glance

Recruiting sites
3 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tooth movement accuracy at subject level across different movement types
Measured over At start of aligner treatment and at end of aligner treatment according to predetermined treatment plan (end of aligner treatment is on average 6-18 months after aligner treatment start).

Conditions

Malocclusion

Explore related trials

Malocclusion

Where it's being run

6 sites across 6 states
California1
New Jersey1
North Carolina1
Texas1
Spain1
United Kingdom1

Who to contact

Freja Freedman
[email protected]
+46 702107415
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subject willing to participate in the clinical investigation, able to understand the intent risks and benefits of the clinical investigation as well as associated time commitment and follow-ups visits.
Subject has signed and dated the informed consent form (ICF) .
Subject aged 18 years or above at time of informed consent.
Subject has permanent dentition (i.e., all 2nd molars).
Subject with a dental malocclusion, consistent with Levels 1 and 2 case complexity and within the clinical references as defined in the SureSmile Case Selection Guide.
Crowding or spacing must be ≤6mm present in one or both arches consistent with level 1 and 2 of case complexity.
Midline deviation must be ≤3 mm consistent with level 1 and 2 of case complexity.
Overjet must be ≤4 mm consistent with level 1 and 2 case complexity.
Overbite must be ≤3 mm consistent with level 1 and 2 case complexity.
Anterior open bite must be ≤1 mm, consistent with level 1 and 2 case complexity.

Exclusion

Subjects unlikely to comply with investigational procedures, or unlikely to come back for follow-up visits, as judged by the Investigator.
Subject that presents a dental malocclusion classified as level 3 case complexity, as defined in the SureSmile Case Selection Guide.
Subjects who have completed aligner therapy within the last 12 months or who are in active orthodontic treatment.
Subjects with active periodontal disease or other unresolved dental conditions such as active cavities, active periodontal disease.
Subjects with treatment plans requiring transverse correction requiring expansion greater than 4 mm per arch or 2 mm per quadrant, or any skeletal transverse correction.
Treatment plans requiring sagittal correction exceeding a half-cusp discrepancy (i.e., \>½ unit) in molar or canine relationships.
Subjects with treatment plans require vertical correction beyond Level 1 and 2 thresholds (i.e., overbite \>3 mm or anterior/posterior open bite \>1 mm), or vertical elastics exceeding 3 mm.
TMJ (Temporo-Mandibular Join) disorders or history of headaches or migraines.
Participants with known history of plastic allergies.
Subjects with presence of skeletal discrepancies necessitating orthognathic surgery, rapid palatal expansion, other orthopedic intervention, unilateral or bilateral cross-bites, mandibular deviations in association with the diagnosed malocclusion
The use of TADs (Temporary Anchor Devices), plates, other fixed anchorage ancillaries or the use of functional appliances (distalizers, growth modification devices), any approach involving orthopedic or skeletal sagittal correction or the use of hybrid fixed appliances are not considered part of the scope of this clinical investigation and these subjects are not eligible.
Uncontrolled para-functional habits, e.g., bruxism.
Any other condition that would make the subject unsuitable for participation, including but not limited to:
Unstable psychiatric illness.
Recent myocardial infarction (\< 3 months\*).
Recent cerebrovascular accident (\< 3 months\*).
Recent cardiac-valvular prosthesis placement (\< 3 months\*).
Hemorrhagic diathesis.
Severe liver dysfunction.
Known or suspected current malignancy.
Known pregnancy at the time of enrolment.
Previous enrolment in the present clinical investigation.
Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and the clinical investigation site).
Participation in another clinical investigation that may interfere with the present clinical investigation.

What this trial measures

  • Tooth movement accuracy at subject level across different movement typesAt start of aligner treatment and at end of aligner treatment according to predetermined treatment plan (end of aligner treatment is on average 6-18 months after aligner treatment start).

    The primary objective of this clinical investigation is to provide a detailed assessment of tooth movement accuracy at subject level across different movement types. For each patient, all teeth will be evaluated in five dimensions of movement: 1. Mesiodistal translation \[mm\] 2. Buccolingual translation \[mm\] 3. Intrusive/extrusive movement \[mm\] 4. Mesiodistal angulation \[degrees\] 5. Buccolingual torque \[degrees\] Accuracy will be determined by comparing the predicted versus achieved tooth positions for 16 teeth in each subject using the formula: "Percentage of accuracy" =100 - \[(\|predicted-achieved\| / \|predicted\|) \*100\]" Subject effectiveness is the overall mean of all the collected "Percentage of accuracy" values.